ABX203 (HeberNasvac) Granted Cuban Marketing Authorization

[vootoodoo]

"ABIVAX (Paris:ABVX) (Euronext Paris: FR0012333284 – ABVX), an emerging leader in developing and commercializing anti-viral and vaccine therapies for diseases like HIV/AIDS and chronic Hepatitis B (CHB) and the Center for genetic Engineering and Biotechnology (CIGB), a global leader in biotechnology, today announced that CECMED, the Cuban regulatory authorities, granted the CIGB their first marketing authorization application for ABX203, a first-in-class therapeutic vaccine for treatment of CHB, under the trade name HeberNasvac."

http://www.businesswire.com/news/home/20151208006286/en/ABIVAX-ABX203-HeberNasvac-Granted-Cuban-Marketing-Authorization

[stef2011]

yes i agree for those who will be able to afford it it is just a try, i also dont believe it has any curative effect maybe only a boost on those with very low hbsag which are already on the path of clearance thanks to previous peg or decades of nucs

i really dont like the fact we dont have any real values, a serious trial should have all values hbsag quant/hbvdna per patients baseline and eot.the fact no hbsag quant was reported is strange

[StephenCastlecrag]

The price of USD2,500 per injection is only a rumour. In China, as in everywhere else, you get all types of people, making speculations or mischief. My point is, better check the price before going over. ABX203 is so new, so I don't believe anyone know at this stage what it can and cannot do, let alone, how many injections. The clinical trials being conducted in Australia and Asia hopefully will give more clues.

[stef2011]

do they know if the price will be 2500usd also in cuba, asia and south america?2500usd sounds too high for those markets

[stef2011]

condor.com prices as low as 268€ booking ealry from london to cuba

[stef2011]

thanks but hope they have direct flights from europe

[stef2011]

i did not ask for the price, 2500usd is a rip off, if they keep making fantasy price like for hcv every country will end up making its own generic version, anyway lets hope for normal prices

i think it worths try 6 months combo with peg, nucs, vit d or for those with very low hbsag under peg or nucs

[Royal36]

Thank you Stif2011. From here US you can be connected via JetBlue i guess. Stephen how many injections average d we need for the max outcome? Any idea?

[stef2011]

we got the answer from one of the emails i sent

HeberNasvac is already registered in cuba and will be available after march 2016

march is close anybody with experience with getting cheap flights to cuba?which air companies?
i ll definitely try it since it may help with my low hbsag

i think this vaccine may be helpfull after peg or years of nucs when hbsag gets close to 1000iu/ml or less

[StephenCastlecrag]

Do you have any idea about the price? On the Chinese forum, there is rumour(unconfirmed) that it will cost $US2,500 per injection.

[stef2011]

treid emailing to most of them now, previously i just email to information manager

[mer971]

Maybe that website is just commercial, better to email on their principal , secure, website (green sign http on top)

[stef2011]

i did both in english and spanish in same email

[StephenCastlecrag]

Very annoying! Why have email address when you don't reply!

[stef2011]

http://www.cigb.edu.cu/index.php/en/

no answer from these guys, maybe international contracts problems or maybe they dont look at emails

[StephenCastlecrag]

They never reply. Maybe if you write in Spanish?

[mer971]

Cheers to Cuba,
Important that finally, after nucs another hope is coming out soon.
Tickets for Cuba

[needadvicewithhep]

It might say that but its such a highly regulated process with many pit falls.

Lets hope they are correct

[mer971]

Steff, article says that will be granted soon in late 2016 for Europe. So, we are close to defeat it

[Royal36]

Frredands u r in here too...lol

[March06]

or why not they report if there is any hbsag loss associated with ABX203 use

[March06]

i dont know why the main target of drug Makers is to control disease not fully cure it! they don't even care to talk about HbsAg Quantitative Before and After?

[studyforhope]

The Cuban center  that developed the vaccine has a website , with news.
http://www.cigb.edu.cu/index.php/en/

Interestingly, the approval of the start of the marketing application is not yet part of the news there.

[stef2011]

has anyone knowledge about the way cuba put drugs on the market?

where shall we look/ask for this new vaccine, hospitals, government agencies, normal pharmacy or directly the vaccine producer in cuba?

[needadvicewithhep]

Its kinda of funny that cuba has never really stood out as somewhere with high hep b prevelance.

I know they do as a nation have a good reputation for medical facilities though

[studyforhope]

It is a very positive signal from the cuban authorities. It is unclear however if this would speed up approval in the EU, certainly not before the phase III trial is completed inclusive the follow up.

[needadvicewithhep]

But its surely a signal of intent from all involved in cuba no? Also that getting this on the market long prior to any competitors will give them the opportunity to jack up the price maybe?

[Royal36]

Sorte according to his comment another one year till the market in Cuba.